Indications and uses
Temporarily relieves: occasional minor irritation, pain, sore throat and sore mouth cough due to minor throat and bronchial irritation as may occur with the common cold
Chloraseptic Total Sore Throat and Cough
- Manufacturer
- Prestige Brands Holdings, Inc.
- Effective date
- 2025-10-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 01:40:14
Label at a glance#
ProductChloraseptic Total Sore Throat and Cough
Active ingredientMENTHOL, BENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure14 sections
Dosage and administration
Adults and children over 12 years of age: 2 lozenges every 4 hours – not to exceed 12 lozenges every 24 hours. Children 6-12 years of age: 1 lozenge every 4 hours – not to exceed 6 lozenges every 24 hours. Children under 6 years of age: do not use
Contacts and useful links#
Websitewww.chloraseptic.com
www.chloraseptic.com
www.chloraseptic.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients
(in each lozenge)
Benzocaine 6 mg
Purpose
Oral pain reliever
Active ingredients
(in each lozenge)
Dextromethorphan HBr 5 mg
Purpose
Cough Suppressant
Active ingredients
(in each lozenge)
Menthol 10 mg
Purpose
Oral pain reliever
Uses
Temporarily relieves:
- occasional minor irritation, pain, sore throat and sore mouth
- cough due to minor throat and bronchial irritation as may occur with the common cold
Warnings
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
∙ pale, gray, or blue colored skin (cyanosis)
∙ headache
∙ rapid heart rate
∙ shortness of breath
∙ dizziness or lightheadedness
∙ fatigue or lack of energy
Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.
Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor.
Do not use
- this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product
- for teething
- in children under 6 years of age
Ask a doctor before use if you have
- a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- a cough is accompanied by excessive phlegm (mucus)
When using this product
do not exceed recommended dosage.
Stop use and ask a dentist or doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
- cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition.
If pregnant or breast-feeding,
ask a health care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- Adults and children over 12 years of age: 2 lozenges every 4 hours – not to exceed 12 lozenges every 24 hours.
- Children 6-12 years of age: 1 lozenge every 4 hours – not to exceed 6 lozenges every 24 hours.
- Children under 6 years of age: do not use
Other information
- Store between 15ºC - 30º (59ºF - 86ºF)
- Protect from moisture.
- Check expiration date before using.
Inactive ingredients
Corn Syrup, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Glycerin, Soy Lecithin, Sucrose, Water
Questions?
1-800-552-7932 or www.chloraseptic.com
PRINCIPAL DISPLAY PANEL
Chloraseptic® Total SORE THROAT + COUGH Lozenges
Menthol/Benzocaine Oral Anesthetic/Analgesic
Dextromethorphan HBr Cough Suppressant
15 lozenges | Wild Cherry
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1045532 | benzocaine 6 MG / dextromethorphan HBr 5 MG / menthol 10 MG Oral Lozenge | PSN | 6 |
| 1045541 | Chloraseptic Total Sore Throat + Cough 10 MG / 6 MG / 5 MG Oral Lozenge | PSN | 6 |
| 1045541 | benzocaine 6 MG / dextromethorphan hydrobromide 5 MG / menthol 10 MG Oral Lozenge [Chloraseptic Sore Throat + Cough] | SBD | 6 |
| 1045532 | benzocaine 6 MG / dextromethorphan hydrobromide 5 MG / menthol 10 MG Oral Lozenge | SCD | 6 |
| 1045541 | Chloraseptic Sore Throat + Cough (Benzocaine 6 MG / Dextromethorphan Hydrobromide 5 MG / Menthol 10 MG) Oral Lozenge | SY | 6 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67172-016-11 | Chloraseptic Total Sore Throat and Cough | 15 in 1 BLISTER PACK | LOZENGE | 15 | 6 | |
| 67172-016-11 | Chloraseptic Total Sore Throat and Cough | 1 in 1 CARTON | LOZENGE | 1 | 6 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZOCAINE | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| BENZOCAINE | ACTIVE MOIETY | U3RSY48JW5 | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| CORN SYRUP | INACTIVE INGREDIENT | 9G5L16BK6N | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Chloraseptic Total Sore Throat and Cough
- Menthol and Benzocaine and Dextromethorphan Hydrobromide
- MENTHOL
- BENZOCAINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- CORN SYRUP
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- LECITHIN, SOYBEAN
- SUCROSE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67172-016 | 67172-016-11 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| CORN SYRUP | 9G5L16BK6N | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| SUCROSE | C151H8M554 | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2024-12-06 | full-release | 2026-06-01 00:40:22 |
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | TABLET / ORAL | 14.07 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | POWDER, FOR SUSPENSION / ORAL | 39 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SYRUP / ORAL | 600 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | TROCHE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CAPSULE / ORAL | 20 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | ELIXIR / ORAL | 400 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Chloraseptic Total Sore Throat and Cough | MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE | Prestige Brands Holdings, Inc. | 6b1a50d0-be54-4fcb-b5e2-b47abf3555c0 | 2025-10-23 | Warnings | 67172-016-11 67172-016 67172001611 297845ee-691e-434a-8958-a4f5df9635e0 6b1a50d0-be54-4fcb-b5e2-b47abf3555c0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.